QA Engineer

Purpose of the position

The Quality Assurance Engineer (QA Engineer) provides hands-on support of the Company's Quality  Management System, in particular the complaint and CAPA management in our overall efforts to improve on our quality management system, be a strong advocate for our customers to resolve quality issues and achieve pre-market approvals. The QA Engineer Engineer’s primary responsibilities include assuring the full implementation of the complaint handling/vigilance system, compliance to international regulatory requirements, the implementation and maintenance of an effective communication with customers, support product distribution. The QA Engineer will also assure the maintenance of quality and regulatory documentation.

Responsibilities & duties:

Regulatory Compliance

• Ensures regulatory compliance to applicable the relevant international country-specific requirements and policies.
• Maintains a state of compliance control for ISO13485, MDSAP, EU Medical Device Directives, EU Medical Device Regulations and Quality System Requirements
• Ensures implementation of new and changing regulations
• Provides documentation in support of regulatory submissions and customer requests
• Supports implementation and execution of the regulatory compliance requirements

Complaints, CAPAs and NCRs

• Timely reporting the complaints into the document control platform (e.g. Greenlight Guru)
• Supports the complaint evaluation and investigation, including failure analysis.
• Reviews quality and manufacturing records, including DHRs, NCs, CAPAs, complaint records, failure analysis data and reports, and risk documentation.
• Supports trending and risk analysis; evaluate risk to patient.
• Assists or leads in the identification and activities of CAPAs and NCRs
• Maintains all relevant complaint handling and vigilance documents in a compliant manner
• Submit reportable events to regulatory agencies/ customers
• Communicates effectively and in a timely manner to customers

Quality Assurance

• Ensure compliance with ISO 13485, MDD/ MDR and other applicable regulations and standards
• Establish, follow, and maintain Quality Management System procedures, work instructions, and other processes
• Participate in the authorities’ inspections, ISO certification and surveillance audits and other audits

Supplier Quality Assurance

• Interact and coordinate activities with other departments, external vendors, and customers
• Support the suppliers/ vendors onboarding and sourcing process
• Support and verifies the execution of the suppliers’ CAPA

Internal and external audits

• Support internal, external, and customer audits of the SQA program
• Perform quality reviews, audits, investigations, and CAPAs
• Identify areas of improvement and implement plans to correct and prevent problems.

Leadership

• Integrate knowledge of the Quality Policy and Corporate Objectives into work practices to support the business
• Work cross-functionally with Commercial, Sourcing, SQA, RA, R&D to assure high quality complaint investigations
• Lead the QA projects and promote the Quality and Regulatory Culture through the company

Academic & Formal Qualifications

• A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices
• or four years of professional experience in regulatory affairs or in quality management systems relating to medical devices
• knowledge of the medical devices EU regulations
• knowledge of the ISO 13485 or ISO 9001 standards
• ASQ certification (Certified Quality Quality Engineer, Certified Quality Auditor, Certified Quality, Engineer)

Work Experience & Skills

• Experience in Quality Assurance for medical devices
• Good working knowledge of the Microsoft Office
• Writing and approving standard operating procedures and work instructions

• Experience in auditing
• Experience in the manufacturing and design of medical devices
• Experience in the quality control and quality assurance of medical devices/ PPE
• products/ Biocides/ Cosmetics or Veterinary products